13 May 2019 - In the classic 1967 film “The Graduate,” young Benjamin Braddock was given one word of advice for his future: plastics.
In that spirit, I’d like to offer Dr. Ned Sharpless, the new acting commissioner of the Food and Drug Administration, two words of advice for the future of the FDA: data standards.
Like many other experts, I grow increasingly alarmed by the slow progress in the development, implementation, and acceptance of data standards for clinical trials. As the clock ticks, the capital costs and the human costs of inaction are mounting. No matter where my work takes me, I always return to the urgent need for data standards.